This invention relates to systems and methods for processing blood, e.g., for filtration, pheresis, or other diagnostic or therapeutic purposes.
There are many types of continuous and intermittent blood processing systems, each providing different therapeutic effects and demanding different processing criteria.
For example, hemofiltration emulates normal kidney activities for an individual whose renal function is impaired or lacking. During hemofiltration, blood from the individual is conveyed in an extracorporeal path along a semipermeable membrane, across which a pressure difference (called transmembrane pressure) exists. The pores of the membrane have a molecular weight cut-off that can thereby pass liquid and uremic toxins carried in blood. However, the membrane pores can not pass formed cellular blood elements and plasma proteins. These components are retained and returned to the individual with the toxin-depleted blood. Membranes indicated for hemofiltration are commercially available and can be acquired from, e.g., Asahi Medical Co. (Oita, Japan).
After hemofiltration, fresh physiologic fluid is supplied to toxin-depleted blood. This fluid, called replacement fluid, is buffered either with bicarbonate, lactate, or acetate. The replacement fluid restores, at least partially, a normal physiologic fluid and electrolytic balance to the blood. Usually, an ultrafiltration function is also performed during hemofiltration, by which liquid is replaced in an amount slightly less than that removed. Ultrafiltration decreases the overall fluid level of the individual, which typically increases, in the absence of ultrafiltration, due to normal fluid intake between treatment sessions.
Following hemofiltration, fluid balancing, and ultrafiltration, the blood is returned to the individual.
Various aspects of the invention provide systems and methods for conducting hemofiltration at a treatment site. The systems and methods make use of a hemofiltration machine that is installed at the treatment site. The machine includes a controller having at least one selectable therapy function for carrying out a hemofiltration task and generating a data output based upon the hemofiltration task. The machine also includes an interface coupled to the controller.
According to one aspect of the invention, the interface has an input for an operator to select the therapy function. A local transmitting/receiving device is linked to the controller at the treatment site. The local transmitting/receiving device includes a function for receiving the data output of the controller and formatting the data output for remote transmission from the treatment site. The system further includes a main data base server installed at a main site remote from the treatment site. The main data base server is linked to the local transmitting/receiving device. The main data base server includes a function for receiving the formatted data output of the local transmitting/receiving device and processing the formatted data output according to pre-programmed rules to generate a processed output.
According to another aspect of the invention, the controller has a safety monitoring function, which generates a safety alarm output. The interface is coupled to the controller and has an input for an operator to select the therapy function, as well as output for notifying the operator of the safety alarm output. In this embodiment, the local transmitting/receiving device, which is linked to the controller at the treatment site, includes a function for receiving the data output and safety alarm output of the controller and formatting the data output and safety alarm output for remote transmission from the treatment site. The main data base server, which is installed at a main site remote from the treatment site, is linked to the local transmitting/receiving device. The main data base server includes a function for receiving the formatted data output and formatted safety alarm output of the local transmitting/receiving device. The function processes the formatted data output and formatted safety alarm output according to pre-programmed rules to generate a processed output.
According to yet another aspect of the invention, the controller has a safety monitoring function which generates a safety alarm output and underlying safety data. The interface coupled to the controller has an input for notifying the operator of the safety alarm output. In this embodiment, the controller is free of a context-sensitive help function. In this arrangement, the main data base server, which is installed at a main site remote from the treatment site, is linked to the local transmitting/receiving device. The main data base server includes a first function to receive the formatted safety data output for processing according to pre-programmed rules. The first function generates a processed output including context-sensitive help pertaining to the alarm condition. The main data base server also includes a second function, which transmits the processed output to the local transmitting/receiving device. The transmitting/receiving device includes a function for displaying or printing the processed output.
According to these various aspects of the invention, being linked to the main data base server by the local transmitting/receiving device, the machine acts as a satellite. The machine performs specified therapy tasks while monitoring basic safety functions and providing the person at the treatment location notice of safety alarm conditions for resolution. Otherwise, the machine transmits procedure data to the main data base server. The main data base server relieves the machine from major data processing tasks and related complexity. The main data base server, remote from the machine, controls the processing and distribution of the data, including the flow of information and data to the person undergoing therapy.
The local transmitting/receiving device can be linked to the controller by various means, including, e.g., electrically, phone lines, optical cable connection, infrared light, or radio frequency, using cordless phone/modem, cellular phone/modem, or cellular satellite phone/modem, or combinations thereof. The local transmitting/receiving device can also include, e.g., a laptop computer, or a handheld PC device, or web tablet, or cell phone, or combinations thereof. The local transmitting/receiving device can be linked to the main data base server by means including a local area network and the Internet.
In one embodiment, at least one satellite server is installed at a site remote from the treatment site and the main site. The satellite server is linked to the main data base server, including a function to receive the processed output.
The satellite server can comprise, e.g., an inventory server, which is operative to generate a responsive output based upon the processed output including equipment inventory information. In one embodiment, at least one remote component supply facility can be linked to the inventory server to receive the equipment inventory information.
The satellite server can also comprise, e.g., a service server, which is operative to generate a responsive output based upon the processed output including component status information. In one embodiment, the service server can include a function to process the component status information according to preprogrammed rules and generate service-related output including a diagnostic report, or a service request, or a maintenance schedule, or combinations thereof. At least one remote service facility can be linked to the service server to receive the component status information.
The satellite server can also comprise, e.g., a treatment monitoring server, which is operative to generate a responsive output based upon the processed output including treatment information. In one embodiment, at least one remote monitoring facility can be linked to the treatment monitoring server to receive the treatment information.
In one embodiment, the main data base server includes a function to download to the local transmitting and receiving device a control program to execute a specified task function using the machine. In this arrangement, the controller includes a function to download the control program from the local transmitting and receiving device for execution by the machine.
In one embodiment, several hemofiltration machines, each at a different treatment site, are individually linked to the main data base server through a local transmitting/receiving device. In this arrangement, the main data base server generates a processed output specific to each treatment site. In this arrangement, the main data base server can also generate a consolidated output based upon the processed outputs specific to each treatment site.
Another aspect of the invention provides a hemofiltration system that comprises a hemofiltration machine including a chassis. At least one flow controlling element is on the chassis. The machine also includes a controller for the hemofiltration machine to operate the flow controlling element to carry out a processing task in response to a control program. The controller includes an input on the chassis for reading coded indicia. The system includes an extracorporeal circuit for circulating blood from an individual through a hemofilter.
In one embodiment, a fluid processing cartridge holds the extracorporeal circuit for mounting as an integrated unit on the chassis in operating engagement with the flow controlling element and for removal as an integrated unit from the chassis. The fluid processing cartridge carries coded indicia incorporating a control program for the controller. The coded indicia is readable by the input in response to mounting the fluid processing cartridge on the chassis, to thereby transfer the control program to the controller for execution.
In another embodiment, the extracorporeal circuit is mountable on the chassis in operating engagement with the flow control element. An overlay is also mountable on the chassis. The overlay carries a coded indicia incorporating a control program for the controller. The coded indicia is readable by the input in response to mounting the overlay on the chassis, to thereby transfer the control program to the controller for execution.
The control program can command the flow controlling element, e.g., to carry out a prescribed hemofiltration protocol, or a prescribed diagnostic protocol for the machine, or a prescribed service protocol for the machine.
Another aspect of the invention provides a system for conducting hemofiltration comprising a hemofiltration machine. The machine includes a controller and flow controlling elements coupled to the controller to convey blood through a hemofilter to remove waste fluid and supply replacement fluid.
An interface is coupled to the controller. The interface has an input for an operator to select a therapy task function. The interface is selectively operable in a first input mode to prompt an operator to input desired processing parameters including an ultrafiltration flow rate and blood flow rate. The interface is also selectively operable in an alternative input mode to prompt an operator to input desired processing objectives including at least one of a desired filtration factor value and a desired ultrafiltration volume.
In one embodiment, in the alternative input mode, the interface prompts the operator to input a desired filtration factor value, a desired ultrafiltration flow rate, and a desired replacement fluid flow rate. In this arrangement, the controller commands the flow controlling elements to control blood flow rate based upon a prescribed relationship among the filtration factor value, the ultrafiltration flow rate, and the replacement fluid flow rate.
In one embodiment, in the alternative input mode, the interface prompts the operator to input a desired filtration factor value, a desired ultrafiltration flow rate, and a desired blood flow rate. In this arrangement, the controller commands the flow controlling elements to control replacement fluid flow rate based upon a prescribed relationship among the filtration factor value, the ultrafiltration flow rate, and the blood flow rate.
In one embodiment, in the alternative input mode, the interface prompts the operator to input a desired ultrafiltration volume. In this arrangement, the controller commands the flow controlling elements to optimize waste fluid removal through the hemofilter based upon a set waste fluid pressure value.
In one embodiment, in the alternative input mode, the interface prompts the operator to input a desired ultrafiltration volume. In this arrangement, the controller commands the flow controlling elements to optimize waste fluid removal through the hemofilter based upon a set arterial pressure value.